Clearance Summary
Endophys Blood Pressure Monitor received FDA 510(k) clearance under submission number K160945, sponsored by Endophys Holdings, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-09-26.
- Submission: K160945
- Applicant / Sponsor: Endophys Holdings, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1110
- Decision date: 2016-09-26
Classification & Regulation
This clearance is catalogued under FDA product code DSK and 21 CFR 870.1110, within the Cardiovascular review panel as a Class II device.